Five Biotech Companies File for IPO in Early 2024, Highlighting Cell and Gene Therapy as Key Investment Themes

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CG Oncology, a leader in oncolytic viruses, submitted its IPO application on January 2. In the filing with the U.S. Securities and Exchange Commission, the company stated that the net proceeds from its initial public offering would reach $181.1 million. If the underwriters exercise their over-allotment option in full, this figure could potentially rise to $209 million.

CG Oncology, founded by Dr. Paul DeRidder in 2010, has its lead product CG0070, an intravesical oncolytic viral therapy for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC) patients who are unresponsive to BCG, currently in Phase 3 clinical trials. At the same time, this drug is also undergoing a Phase 2 clinical study in combination with Keytruda (K药) for the same indication.

In December 2023, the interim analysis results of the latest Phase III BOND-003 trial showed,In 66 evaluable patients, the complete response (CR) rate of CG0070 in treating high-risk BCG-unresponsive non-muscle invasive bladder cancer reached an impressive 75.7% (50/66).。The baseline data of the patients are as follows:

▲ Specific data (Source: Official website)

Kyverna Therapeutics, Inc. is a pioneer in the field of autoimmune CAR-T, established in 2018, focusing on developing CAR-T therapies for autoimmune diseases, with a research pipeline including treatments forLupusNephritis, systemic sclerosis, myasthenia gravis, multiple sclerosis, inflammatory bowel disease and other diseases CAR-T therapy.

A few days ago, Kyverna announced that its CD19 CAR-T therapy KYV-101 received Fast Track designation from the U.S. FDA for the treatment of multiple sclerosis (MS). The IND application for the phase 2 clinical trial of KYV-101 in treating MS, named KYSA-7, was approved by the FDA earlier this month.This means that the FDA remains optimistic and positive about CAR-T therapy for autoimmune diseases, and autoimmune diseases are expected to become a new avenue for CAR-T in the future.。

Metagenomi, Inc. is a gene-editing therapy company planning to raise up to $100 million through an initial public offering. The company was co-founded in 2018 by Brian Thomas and Jillian Banfield, metagenomics researchers at the University of California, Berkeley. Metagenomi is committed to developing potential therapeutic treatments through next-generation gene-editing systems. Its core strategy involves leveraging vast amounts of metagenomic data, using AI-based cloud computing technology to discover natural nucleases, and modifying them to create gene-editing therapies.

According to reports,The nuclease developed by the company surpasses the existing CRISPR-Cas9 system in gene editing efficiency, with an editing efficiency of over 90%, and some even exceeding 95%.The company has developed a rich set of gene editing tools, and based on these tools, Metagenomi has established a robust pipeline for the development of gene editing therapies. This includes treatments for Hemophilia A (Factor VIII knock-in), PH1 (Moderna, HAO1 knock-down), TTR (in collaboration with Ionis), AGT (in collaboration with Ionis), among others.

Alto Neuroscience is an AI pharmaceutical company founded in 2019 by Amit Etkin, a psychiatry professor at Stanford University. It is dedicated to leveraging an artificial intelligence platform to develop treatments for depression andSpiritSchizophreniaThe company plans to raise up to 100 million US dollars through its initial public offering.

In December last year, Alto Neuroscience, Inc. announced positive results from the Phase 2a clinical trial of its investigational therapy ALTO-300 for the treatment of major depressive disorder (MDD) at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

ArriVent Biopharma, Inc. is a biotechnology company that recently announced plans to go public on Nasdaq, raising approximately $135 million. Founded in 2021, the company is committed to accelerating the global development of innovative drugs. Its partners include InnoCare Pharma and Allist Pharma, among others. To date, ArriVent has completed two rounds of financing, with a total amount exceeding $300 million.

According to the company's official website, the founder of ArriVent Biopharma, Inc. is Dr. Zhengbin Yao, who has over 25 years of experience in the biotechnology and pharmaceutical fields. Before founding ArriVent Biopharma, Inc., Yao established Viela Bio, which was later acquired by Horizon Therapeutics for $3 billion. Prior to joining Viela Bio, he held leadership roles in research and development at MedImmune, AstraZeneca, and Genentech.

Compared with the market downturn last year, the new year has just passed less than a month, and there has already been an obvious IPO boom, which is indeed surprising. PwC analysts predicted last month that the number of IPOs may rebound starting from 2024.It is not difficult to see from the above companies' applications for IPO that the IPO market seems to be regaining vitality, butMarket recovery still needs time to verify, and it also requires the internal and external environment to gradually optimize.

Even though the number of IPOs has increased somewhat, the threshold for IPOs has not decreased compared to 2021; instead, it has risen. The backlog of IPOs in the U.S. market has not diminished, and the companies applying for IPOs are all core companies in their respective niche fields or companies with a certain level of competitiveness.

According to PwCSaid, "The previous lack of vitality in the IPO market has limited the ability of innovative startups to raise necessary funds, making it difficult for them to advance their projects through clinical stages.Moreover, these successfully listed companies are likely to be those with strong performance in clinical data."Although some IPOs performed well last year, we still need to wait and see whether early-stage companies this year will end up trading below their issue price due to poor market conditions." In other words, those able to undergo an IPO are always the minority. Even if an IPO experiences a drop on the first day of trading, it has become the norm. It is highly likely that more and more companies may not be suitable for the current market in the future.

Overall, the biopharmaceutical industry has faced numerous challenges in recent years, and today’s biopharmaceutical investment market is still in a process of spiraling decline. The reason for this difficulty lies in the accumulation of past bubbles and the current external environmental challenges, which have placed it in an awkwardly high position.But biopharmaceuticals belong to a long-cycle and resilient track, which often requires a vision of 5 years, 10 years, or even longer.The defoaming of the pharmaceuticals capital market should not be overly pessimistic; a market correction will brew more opportunities. The pharmaceutical companies that can weather the cycle and break through the blockade are the real gems.